# FDA 483 - Gene Logic, Inc. - March 25, 2024

Source: https://www.keypedia.com/records/483/gene-logic-inc/f9024704-3cc3-4082-8c05-fe4c17567cc7

> FDA 483 for Gene Logic, Inc. on March 25, 2024. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Gene Logic, Inc.
- Inspection Date: 2024-03-25
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of BASI Gaithersburg, LLC dba Inotiv Gaithersburg, a non-clinical laboratory, revealed deficiencies in their standard operating procedures. The firm's written procedures for nonclinical laboratory studies were found to be inadequate in ensuring the quality and integrity of generated data, specifically failing to require accurate recording of original experimental data.

## Related Officers

- [investigator](https://www.keypedia.com/people/gabrielle-j-swain/55f33430-41dc-4fae-bac0-ec6ea340feb6)
- [issuing_officer](https://www.keypedia.com/people/mark-j-seaton/640c2deb-25ff-4e2e-8f48-d15d31f9c5bf)
- [Arianne L. Motter](https://www.keypedia.com/people/arianne-l-motter/79e287ab-0ef1-41ef-aae2-f13483d3cc93)

Company: https://www.keypedia.com/companies/gene-logic-inc/7b9e6dcf-a764-4435-b4ba-694e2904d871

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64